Comparative Aesthetic Analysis Between Titanium and Ceramic Implants

NCT04707677 | Completed DMC

• 1 other identifier: CI_RCT_US16
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The aim of this randomized clinical trial was to compare ceramic and titanium implants with respect to the esthetic and clinical parameters, and patient reported outcome measures (PROMs). Material and methods: Thirty patients received thirty implants (8-12 mm in length, 3.3 mm diameter and a tissue level design) to replace the absence of a single tooth in the anterior maxilla. Patients were randomly allocated to receive a ceramic or a titanium implant. Esthetic and clinical parameters and PROMs were evaluated 18 months after surgery.

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (1)

• The primary outcome was the Implant Crown Aesthetic Index (ICAI).

  It consists of nine sections: (i) mesiodistal dimension of the crown, (ii) position of the incisal edge of the crown, (iii) labial convexity of the crown, (iv) color and translucency of the crown, (v) crown surface, (vi) position of the gingival margin of the peri-implant mucosa, (vii) position of the interdental papilla, (viii) contour of the vestibular mucosa and (ix) color and surface of the vestibular mucosa. These sections were compared with the adjacent and contralateral tooth as a reference and assigned the following score: 0, excellent; 1 or 2 satisfactory; 3 or 4 moderate; 5 or more bad (Meijer et al., 2005).

  36 months

Study Arms (2)

CONTROL GROUP

ACTIVE COMPARATOR

Implant surgery placement. Tissue Level SLA Titanium implant (Straumann Standard Plus Narrow Neck CrossFit®; Institut Straumann, Basel, Switzerland). The implant had a diameter of 3.3 mm and a polished neck of 1.8 mm. The length of the implants was 8, 10 and 12 mm and was chosen according to the patient's anatomy.

Device: Titanium and ceramic dental Implants

TEST GROUP

EXPERIMENTAL

Implant surgery placement. Tissue Level Ceramic monotype implant was placed (Straumann PURE Ceramic implants®; Institut Straumann, Basel, Switzerland). The implant had a diameter of 3.3 mm and a polished neck of 1.8 mm. The length of the implants was 8, 10 and 12 mm and was chosen according to the patient's anatomy.

Device: Titanium and ceramic dental Implants

Interventions

Titanium and ceramic dental Implants DEVICE

Two types of implant placement and follow-up to compare the esthetic, clinical and radiographic parameters between them.

CONTROL GROUP; TEST GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Periodontal and systemically healthy patients \> 18 years of age, with good plaque control (\< 25%).
• Patients with a missing tooth in the anterior maxilla (from 13 to 23) with the presence of adjacent natural dentition mesially and distally (single gap). A minimum of 4 months of healing after tooth extraction was required before implant insertion.
• Presence of ≥ 2mm of keratinized tissue.
• Simultaneous bone regeneration was allowed during surgery.

You may not qualify if:

• Intake any medication or presence of any systemic disease that could affect bone metabolism.
• Pregnancy, or lactating women.
• Active periodontal disease
• Smoking \>10 cig/day

Sponsors & Collaborators

• University of Santiago de Compostela: lead

Study Sites (1)

Master Periodoncia

Santiago de Compostela, 15782, Spain

Location

Study Officials

• Juan Blanco

  University of Santiago de Compostela

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctorate in Dentistry

Model Details: Two study groups, test (titanium implants) and control (ceramic implants)

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: January 13, 2021
• Study Start: September 15, 2015
• Primary Completion: June 30, 2017
• Study Completion: March 30, 2020
• Last Updated: December 27, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)